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Mabwell Passes On-Site GMP Inspection by Regulatory Authority of PIC/S Member Country (Jordan) for the Fi

The inspection covered two denosumab injections and gave Mabwell its first recognition from a PIC/S member-country regulator.

  • On Monday, April 20, Mabwell announced its wholly-owned subsidiary T-mab successfully passed an on-site GMP inspection by the Jordan Food and Drug Administration, receiving a 'Compliance' conclusion.
  • This marks Mabwell's inaugural recognition by a Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme member country, as Jordan's GMP standards align with high-level international regulatory requirements.
  • Auditors conducted a comprehensive review of Taizhou Mabwell facilities, equipment, quality systems, and production processes for two denosumab injections: a Prolia biosimilar and an Xgeva biosimilar.
  • Senior Vice President Huiguo Hu said, "Successfully passing this GMP inspection by a PIC/S member country demonstrates that Mabwell's quality management system is gaining increasing recognition," enhancing Middle East biologic accessibility.
  • Mabwell has reached strategic collaborations covering 33 countries for its denosumab injection products, having obtained marketing approval in Pakistan in 2025 to support global expansion.
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The Berkshire EagleThe Berkshire Eagle
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Mabwell Passes On-site GMP Inspection by Regulatory Authority of PIC/S Member Country (Jordan) for the First Time

SHANGHAI, April 20, 2026 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that its wholly-owned subsidiary, T-mab, has successfully passed the on-site GMP inspection conducted by the Jordan Food and Drug Administration (JFDA).…

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Benzinga broke the news in New York, United States on Tuesday, April 21, 2026.
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